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Efficacy of the Brushless Scrub

This study is not yet open for participant recruitment.
Verified April 2012 by Winthrop University Hospital
Sponsor:
Information provided by (Responsible Party):
Theresa Criscitelli, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01583231
First received: February 21, 2012
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

The aim of this research is to examine if the brushless scrub is effective in reducing bioburden on the hands of the operating room (OR) personnel both with a prewash of one minute prior to scrub and without a prewash prior to scrub, and to compare the bioburden reduction between both methods.

Hypothesis I: A soap and water prewash used prior to brushless scrub further decreases bioburden than brushless scrub alone.

Hypothesis II: Brushless scrub is effective in reducing the bioburden measured just after the application of the brushless scrub within 20 seconds of application for both groups.

Exploratory Hypothesis: We will also compare the bioburden measured before and at 1.5 minutes after application of the brushless scrub for both groups.


Condition Intervention
Focus of Study: Handwashing
 Other: Prewash

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Efficacy of the Brushless Scrub

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Reduction of bioburden [ Time Frame: 1.5 minutes after brushless scrub was applied ] [ Designated as safety issue: No ]
    The procedure of swabbing the participants will be measured by using the RUHOF ATP Complete Contamination Monitoring System.


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Prewash
Level 1: participants will be swabbed, then application of brushless scrub, swabbed again
Experimental: Prewash
Level 2: participants will be swabbed, perform a wash with soap and water for 1 minute, dry, apply brushless scrub, swabbed again
 Other: Prewash
The intervention will be the addition of the prewash utilizing non-antimicrobial soap and water.

Detailed Description:

Hand washing by operating room personnel prior to surgical procedures is essential in the prevention of intraoperative infection. The use of the brushless surgical hand hygiene has been used since the CDC stated in 2002 that using a brush and sponge is no longer necessary. Empirical literature supports the reduction of the incidence of bacteria or OR personnel hands with the use of alcohol-based products.

An annotated integrative search of the literature was conducted and conflicting information regarding the use of a prewash prior to the brushless scrub was found. This study can help us utilize the brushless scrub to the fullest capacity and prevent surgical site infections.

The time point at which the outcome measure will be assessed at an individual level will be immediately pre-intervention and also 1.5 minutes after the intervention. For example, within 15 seconds prior to brushless scrub, or prewash, a sample swab will be collected and then another sample swab will be obtained 1.5 minutes later for postintervention measure. The study should take approximately 4 months to complete to get an adequate sample size of individuals for statistical power. The data will be aggregated and presented at a staff in-service within 3 months after data collection and analysis is completed.

  Eligibility

Ages Eligible for Study:   19 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion will consist of all OR personnel and students who scrub for surgical procedures.

Exclusion Criteria:

  • Exclusion will consist of any OR personnel and students whom do not want to participate in the study or those who have not been part of the the routine and mandatory training of proper surgical hand hygiene which occurs annually.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583231

Contacts
Contact: Theresa Criscitelli, MS, RN, CNOR 516 506 2789 tcriscitelli@winthrop.org

Locations
United States, New York
Winthrop University Hospital Not yet recruiting
Mineola, New York, United States, 11501
Contact: Theresa Criscitelli, MS, RN, CNOR            
Principal Investigator: Theresa Criscitelli, MS, RN, CNOR            
Sub-Investigator: Jennifer Auriemma, BSN, RN            
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Theresa Criscitelli, MS, RN, CNOR Winthrop University Hospital
  More Information

Publications:

Responsible Party: Theresa Criscitelli, Director of Perioperative Education, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01583231     History of Changes
Other Study ID Numbers: 302192-1
Study First Received: February 21, 2012
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013